FDA applicant

Dako Denmark A/S

Glostrup4 decisions2008–20171 recall

FDA records 4 decisions for Dako Denmark A/S (Glostrup) from 2008 to 2017: 2 510(k) clearances and 2 original PMA approvals. Most are in product codes NYQ (Chromogenic In Situ Hybridization, Nucleic…) and MYA (Immunohistochemistry Antibody Assay, Estrogen…). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, pathology panel, where it files most

How often FDA has decided Dako Denmark A/S’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2008high 2 (2017) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2014

2008high 1 (2014) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Dako Denmark A/S by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dako Denmark A/S’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Dako”

FDA records each applicant name separately; these may or may not be the same firm.

Dako Corp. 54 Dako North America, Inc. 6 Dako Diagnostics, Ltd. 6 Dako A/S 2

Dako Denmark A/S

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Dako”